Program Description: Barbara Rusin, Sr. Manager Regulatory Compliance at MMS Holdings Inc., and a former FDA Investigator, will be presenting “Everyone Has a Medical History Worth Knowing – Especially Your Study Patient.” She will discuss regulatory implications of enrolling ineligible subjects – to the sponsor and clinical site – and how to prevent this by obtaining and properly reviewing medical histories, and what to do when records are not readily available. The presentation will also touch on the differences in the regulatory landscapes of the US and the EU regarding patient eligibility, health records, and study waivers.

Upon completion of this Seminar, attendees should be able to:

The regulations and guidelines relevant to enrollment of eligible subjects in the EU and US

Why enrollment of an ineligible subject is so concerning to regulatory authorities and the impact on study analysis

Regulatory outcomes of enrollment of ineligible subjects

What medical histories are necessary and how to maintain adequate documentation

To receive contact hours: Purchase the contact hours, sign in at the event, and attend the program. Log on to the ACRP website then “My Courses” to complete the evaluation no later than 30 days following the event and obtain the online certificate.

Contact Hour Cost:

$0 Chapter Members$15 ACRP Members$30 Non-Members

Refund Policy: No refunds

Level: Not specified

Location

Contact

ACRP supports clinical research professionals through membership, training and development, and certification. Founded in 1976, ACRP is a Washington, DC-based non-profit organization with more than 13,000 members who work in clinical research in more than 70 countries.